Codeine Phosphate and Guaifenesin
Dosage form: liquid
Ingredients: Codeine Phosphate 10mg in 5mL, Guaifenesin 100mg in 5mL
Labeler: Virtus Pharmaceuticals LLC
NDC Code: 69543-276
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active Ingredients (In each 5 mL = 1 tsp)||Purpose|
|Codeine Phosphate, USP 10 mg||Antitussive|
|Guaifenesin, USP 100 mg||Expectorant|
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- your cough to help you sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.
Ask your doctor before use if
- you have a persistent cough, this may be a sign of a serious condition
- you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- you have a cough that is accompanied by excessive phlegm (mucus)
- you have chronic pulmonary disease or shortness of breath
- giving to a child who is taking other drugs
When using this product
- giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
- may cause or aggravate constipation
Stop use and ask a doctor if
- symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- do not exceed 6 doses in 24 hours.
|Adults and children 12 years of age and over:||2 tsp (10 mL) every 4 hours, or as directed by a doctor.|
|Children 6 to under 12 years of age:||1 tsp (5 mL) every 4 hours, or as directed by a doctor.|
|Children under 6 years of age:||Consult a doctor.|
Each tsp (5 mL) contains 4 mg sodium.
Store at controlled room temperature 15° to 30°C (59° to 86° F). You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088
Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, menthol flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.
Codeine phosphate and
Guaifenesin oral solution
10 mg/100 mg Per 5 mL
Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate, USP 10 mg
Guaifenesin, USP 100 mg
(WARNING: May be habit-forming)
Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing
16 fl. oz. (473 mL)
|CODEINE PHOSPHATE AND GUAIFENESIN
codeine phosphate and guaifenesin liquid
|Labeler - Virtus Pharmaceuticals LLC (079659493)|